Suture packaging

ABSTRACT

A package for surgical suture material is also provided. The package includes a base and a cover. The cover is configured to be placed adjacent to the base to form the package for surgical suture material and including a plurality of posts extending from an outer surface thereof configured for receiving an information label. The package may further include an information label heat staked to the cover.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/400,686, filed Apr. 7, 2006, which is a continuation-in-part of U.S.patent application Ser. No. 10/891,604, filed Jul. 15, 2004, now U.S.Pat. No. 7,520,382, which claims benefit of and priority to U.S.Provisional Application No. 60/488,464, filed Jul. 18, 2003, thedisclosures of each being incorporated in their entirety herein byreference.

BACKGROUND

1. Technical Field

The present disclosure relates to packages for surgical sutures, andmore particularly to methods and apparatus for packaging surgicalsutures.

2. Discussion of Related Art

A common form of surgical suture package is made of a folded stifftreated paper suture holder contained in a sterile, hermetically sealedenvelope. This envelope is further sealed in a second, usually clear,thermoplastic heat-sealed envelope outer wrap to maintain the sterilityof suture holder and inner envelope. When the suture is to be used, theouter clear wrap is opened, typically in the operating room, and thesealed sterile inner envelope is placed in a sterile area. Operatingroom personnel then open the inner envelope when access to the suture isneeded.

Packages for surgical sutures having needles attached at one or bothends are constructed according to the nature of the suture material andto how the sutures will be used. Generally, the package holds the sutureand attached needles in place, protects them during handling andstorage, and allows ready access to the suture for removal with minimumhandling at the time the suture is to be used.

An important aspect of the design and manufacture of suture packages isthat the suture should be removable without becoming entangled withitself, kinked, coiled or bound in undesired ways. The nature of thesuture material itself may impose limitations on the configuration ofthe package, how the suture is placed within the package, the placementof the needles, or how the suture is drawn from the package.

An exemplary packaging for surgical suture material is disclosed in U.S.Pat. No. 6,076,659. The '659 patent discloses a packaging for surgicalsuture material which has a base from which a wall extends in a spiralmanner. The wall defines a suture duct within the area defined by thebase. The suture duct opens at its first end into a suture-removal area.A cover is located above the suture duct. The spiral wall is provided onits outward-facing side with suture-deflector protrusions spaced apartfrom one another in the course of the suture duct.

A drawback in the case of the previously known packaging for surgicalsuture material is that, when the surgical suture material is beingremoved, the suture can pull tight in the suture retaining area in whichit is guided over several spiral turns. That is, in the attempt toremove the suture from the packaging, the direction of the pulling forceoften causes the suture to move toward locations within the packagingwhich could cause the suture to become bound.

For example, the suture can move within the suture retaining area intoan area which is formed by a junction between the wall extending like aspiral and the cover. The suture retaining area is defined by the spiralwall, the base and the cover. However, the wall in the suture package inthe '659 patent, as well as many other prior art suture packages,extends from the bottom of the package toward the cover. Thus, a gap isfrequently formed at a location which is defined by the junction of thewall and the cover. It is not uncommon for the suture to become wedgedin the gap, thereby making further removal of the surgical suturematerial much more difficult or impossible.

The ability to readily access sutures and efficiently retrieve thesutures from their packaging is of utmost importance, especially whentime is of the essence during a surgical procedure. Although apparatusand methods that adequately provide packaging for surgical suturematerial are known, the problems associated with the sutures becomingbound or otherwise caught within the suture package have not beenentirely eliminated. Thus, a continuing need exists for improved suturepackages which virtually eliminate any possibility of the suturebecoming entangled or caught within the suture package.

SUMMARY

A package for at least one surgical suture is provided. The packageincludes a base and a cover. The cover is configured to be placedadjacent to the base to form the package for at least one surgicalsuture. The cover defines an opening therein to provide access to aneedle and suture contained within the package. The package alsoincludes an outer wall extending from an outer circumference of thebase. The outer wall has a predetermined height such that the outer wallmeets the cover when the cover is placed adjacent to the base. The outerwall defines an outer periphery of a suture retainer area. The packagealso includes a needle park located on an upper surface of the cover formaintaining a needle connected to an end of the surgical suture in afixed position, a platform extending from a bottom surface of the cover,the platform having a peripheral wall for at least partially defining aninner periphery of the suture retainer area, and a plurality of postsextending from first and second arcuate end portions of a lower surfaceof the cover to define an inner periphery of arcuate end portions of thesuture retainer area. At least two of the plurality of posts are joinedby webbing and the posts are dimensioned and configured to engage holesformed in the base to secure the cover to the base. Further, the packageincludes a plurality of posts extending from an upper surface of thecover configured for heat staking a label to the cover.

A package for surgical suture material is also provided. The packageincludes a base and a cover. The cover is configured to be placedadjacent to the base to form the package for surgical suture materialand including a plurality of posts extending from an outer surfacethereof configured for receiving an information label. The package mayfurther include an information label heat staked to the cover. Thepackage may also include an outer wall extending from an outercircumference of the base, the outer wall having a predetermined heightsuch that the outer wall meets the cover when the cover is placedadjacent the base. A plurality of discrete protrusions may be formed onthe outer wall and be configured and dimensioned to maintain thesurgical suture material a predetermined distance from the outer wallsuch that the surgical suture material is removed from a juncture formedby the outer wall and the cover upon assembly of the package. Theprotrusions may extend inwardly toward the center portion of thepackage.

In one embodiment, the suture package may further include a needle parkfor maintaining a needle in a fixed position, wherein the needle isconnected to an end of a suture which is positioned within the sutureretaining area. The needle park may be located on an upper surface ofthe cover and/or on the upper surface of the base. The needle park mayinclude three cantilevered members that provide a three-point contactwith the needle. The needle park may be flexible to accommodate needleshaving different curvatures. A plurality of posts may extend from abottom surface of the cover to form at least one suture retaining area.

In another embodiment, a needle is attached to an end of the suturematerial is positioned within a central region of the base, as definedby the at least one suture retaining area, such that the needle engagesa needle park to maintain the needle in a fixed position. At least onesuture retaining area may be further defined by a wall extending from alower surface of the cover. The cover may have a circumference dimensionwhich is substantially equal to a circumference dimension of the base.

Additionally, provided is a suture package including a base, a coverhaving a lower surface and an upper surface configured to attach to thebase to define an area configure to retain a suture and a label heatstaked to at least a portion of the upper surface of the cover.

Also provided is a method of assembling a suture package. The methodincludes positioning a cover of a suture package with the lower sidefacing upward, winding a suture onto the lower side of the cover,positioning a base over the lowerside of the cover to at least partiallycover the suture, securing the base to the cover and attaching aninformation label to an upper side of the cover. Attaching aninformation label to an upper side of the cover may include heat stakingthe label to the cover. The cover may include a plurality of posts forheat staking the label to the cover.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given above,and the detailed description of the embodiments given below, serve toexplain the principles of the disclosure.

FIG. 1A is a top view of an embodiment of a suture package in accordancewith an embodiment of the present disclosure;

FIG. 1B is a side cross-sectional view of the suture package illustratedin FIG. 1A;

FIG. 1C is a perspective view of a suture package in accordance with anembodiment of the present disclosure;

FIG. 2A is a top view of an embodiment of a suture package in accordancewith an embodiment of the present disclosure;

FIG. 2B is a side cross-sectional view of the suture package illustratedin FIG. 2A;

FIG. 3A is a top view of an embodiment of a suture package in accordancewith an embodiment of the present disclosure;

FIG. 3B is a side cross-sectional view of the suture package illustratedin FIG. 3A;

FIG. 4A is a top view of an embodiment of a suture package having anexternal needle park in accordance with an embodiment of the presentdisclosure;

FIG. 4B is a side cross-sectional view of the suture package having anexternal needle park illustrated in FIG. 4A;

FIG. 5A is a top view of an embodiment of a suture package in accordancewith an embodiment of the present disclosure;

FIG. 5B is a side cross-sectional view of the suture package illustratedin FIG. 5A;

FIG. 6A is a top view of an embodiment of a suture package in accordancewith an embodiment of the present disclosure;

FIG. 6B is a side cross-sectional view of the suture package illustratedin FIG. 6A;

FIG. 7A is a top view of an embodiment of a suture package having anexternal needle park in accordance with an embodiment of the presentdisclosure;

FIG. 7B is a side cross-sectional view of the suture package having anexternal needle park illustrated in FIG. 7A;

FIG. 8 is a perspective view of a suture package in accordance with anembodiment of the present disclosure;

FIG. 9 is a perspective view of a suture package in accordance with anembodiment of the present disclosure;

FIG. 10 is a perspective view of a suture package having a needle parkin accordance with an embodiment of the present disclosure;

FIG. 11 is a perspective view of a suture package having an informationlabel attached to an upper surface of the cover of the suture package inaccordance with an embodiment of the present disclosure;

FIG. 12 is a perspective view of a suture package having an informationlabel attached to an upper surface of the cover of the suture package inaccordance with an embodiment of the present disclosure;

FIG. 13 is a top view of a suture package cover in accordance with anembodiment of the present disclosure;

FIG. 14 is a top view of an inside surface of a suture package base inaccordance with an embodiment of the present disclosure;

FIG. 15 is a perspective view of an outside surface of a suture packagebase in accordance with an embodiment of the present disclosure;

FIG. 16 is a top view of an inside surface of a suture package base inaccordance with another embodiment of the present disclosure; and

FIG. 17 is a perspective view of an outside surface of a suture packagebase in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the presently disclosed suture package and methodtherefor will now be described in detail with reference to the figures,in which like reference numerals identify corresponding elementsthroughout the several views.

Referring now to FIGS. 1A and 1B, there is shown a top view and a sidecross-sectional view, respectively, of an embodiment of a suture packagein accordance with an embodiment of the present disclosure. The packagehas a base 5 and a cover 10. An outside wall 15 rises from base 5 andextends like an oval around a circumference of base 5. Outside wall 15has an upper rim 20 and a lower rim 25. Lower rim 25 is connected to thebase 5. Outside wall 15 is designed having a predetermined height suchthat upper rim 20 engages cover 10, preferably at the circumferencethereof. Thus, when base 5 and cover 10 are moved adjacent each other,the outer circumference of cover 10 is joined with the upper rim 20 ofoutside wall 15 to form an outer wall of the closed suture package.

A suture retaining area 30 is defined on an outer boundary by outsidewall 15, and on an inner boundary by an inner or interior wall 35. Inaccordance with an embodiment of the present disclosure, interior wall35 preferably extends downward from cover 10. Unlike outside wall 15,interior wall 35 is not a continuous loop. Instead, interior wall 35 hasa first end and a second end which will be described in further detailbelow. Adjacent to the first end of interior wall 35, an opening isdefined which allows a first end of a suture 45 to enter into the sutureretaining area 30. Interior wall 35 is also configured to follow theshape of the suture retaining area 30. Thus, at the point of the openingformed by interior wall 35, the end of the interior wall 35 is offsetfrom any other portion of interior wall 35. This offset is necessary tomaintain the shape of the suture retaining area 30 and to provide anopening for the suture 45 to access the suture retaining area 30.

Alternatively, it is contemplated that interior wall 35 may define anouter boundary of a plateau region in the center of cover 10. The heightof the plateau region (also referred to as suture-removal area 85) isconfigured to be equivalent to the height of suture retaining areaprotrusions 40 less the thickness of a needle 70. Accordingly, a needle70 may be positioned on the plateau in suture-removal area 85, on theoutside surface of cover 10. In the case wherein it is desired to parkthe needle on the exterior of the suture package, a spacer may be placedon the plateau in suture-removal area 85. In an alternative embodiment,interior wall 35 defines an oval opening within cover 10. In that case,it is preferred that a needle park 75 is attached to base 5 within thesuture-removal area 85. Therefore, surgical personnel have the abilityto access and remove needle 70 through the opening within cover 10.

Extending downward from cover 10 is structure that partitions the suturepackage into one or more suture retaining areas. More specifically, aplurality of sets of four suture retaining area protrusions 40 defines acorresponding number of suture retaining areas. The sets of sutureretaining area protrusions 40 are displaced radially from a center ofthe cover 10. It is also contemplated that the sets of suture retainingarea protrusions may be configured as more or less than four retainingarea protrusions such that more or less suture retaining areas aredefined. Additionally, it is contemplated that the suture retaining areaprotrusions may be configured as one or more continuous walls whichdefine one or more suture retaining areas.

Suture retaining area protrusions 40 are elongated finger members havinga height which is substantially equivalent to the height of outside wall15. Suture retaining area protrusions 40 are connected on a first end tothe bottom surface of cover 10. A second end of suture retaining areaprotrusions 40 has a post 60 extending therefrom. Posts 60 aredimensioned to fit within holes 65 which are formed in base 5. Holes 65may also be dimples or recesses. Posts 60 may also be heat staked orotherwise welded to base 5 to secure the cover 10 to the base 5. Ascover 10 and base 5 are joined together, posts 60 extending from sutureretaining area protrusions 40 engage holes 65 which are defined by base5. This arrangement provides structural support to the suture package.The ends of the protrusions 40 may, alternatively, be deformed in themanner of rivets after the cover 10 has been fitted onto the base 5 withthe wall 15. Other and/or additional types of connection between thewall 15 and the cover 10 are possible. Thus, e.g., the use of catches,which project at the periphery of the cover 10 and engage with suitablecounterparts at the wall 15, is conceivable.

Also, as a result of the fit between the suture retaining areaprotrusions 40 and the holes 65 in base 5, the possibility of a surgicalsuture sticking in the region wherein the suture retaining areaprotrusions 40 meet base 5, as the suture is being removed from thepackaging, is reliably avoided.

More specifically, since, in a particularly useful embodiment, thesuture is removed through the cover, there will be a tendency for thesuture to move in the direction of the cover 10, which is away from anygap which may form at the junction of the suture retaining areaprotrusions 40 and base 5. Thus, this configuration will further anobjective of this disclosure, that is, to increase the reliability ofthe removability of the suture. Although the alternative embodimentsdescribed herein include various structural differences, a commonfeature of each of the embodiments is that the structure which forms thesuture retaining areas extends from a bottom surface of the cover.

The suture retaining area protrusions 40 define the suture retainingareas 30 on the bottom of cover 10. The embodiment illustrated in FIGS.1A and 1B includes a plurality of sets of four suture retaining areaprotrusions 40 extending radially outward between interior wall 35 andoutside wall 15. Thus, a suture retaining area 30 defines and providesfor four revolutions of suture 45. Also, in this embodiment, the sutureretaining area protrusions 40 are only positioned in the end sections ofthe suture package. The two straight sides 80 of the suture package donot contain any protrusions. Thus, suture 45 is not restrained withindefined retaining areas as the suture traverses each of the two sides80.

A first end 50 of the suture retaining area 30 opens into asuture-removal area 85 which, in the embodiments illustrated in FIGS. 1Aand 1B is arranged in the zone surrounded by the suture retaining area30. The second end 55 of the suture retaining area 30 is closed, seeFIG. 1A. The suture retaining area 30 is closed to the bottom by base 5.

Prior to being placed within a suture package, the suture is typicallyattached to a needle to provide a suture-needle combination. That is, aneedle 70 is fitted onto an end of the suture 45. A needle park assembly75 is provided within the central section of the suture-removal area 5on an outer surface of cover 10 or an inner surface of base 5. Thestructure of needle park assembly 75 may be known to one having ordinaryskill in the art. See, for example, U.S. Pat. Nos. 6,481,569, 5,788,062,5,472,081, 5,180,053, 5,131,533, 5,099,994, and 4,424,898. It iscontemplated that cover 10 includes an opening which permits free accessto the suture-removal area 85. The opening may be a partial opening inthe cover, or a more extensive opening, the advantages of each of whichwill be described below. Surgical personnel can gain access to theneedle and suture through the opening in cover 10 and remove the needlesuture combination by disengaging needle 70 from needle park 75 and thenpulling the suture 45 from suture retaining area 30. It is to be notedthat the needle 70 is positioned within the inner space defined by thesuture 45. This configuration further assists in the removal of theneedle-suture combination from the package.

FIG. 1C illustrates a perspective view of an embodiment of a suturepackage in accordance with the present disclosure. Illustrated in FIG.1C are base 5 and cover 10. A needle 70 is shown positioned within arecessed suture-removal area 85 of cover 10. Thus, needle 70 ispositioned on an exterior surface of the suture package. It is alsocontemplated that needle 70 may reside on base 5. In that case, theneedle 70 may be retrieved from the suture package through an openingdefined in cover 10 which is larger than opening 90.

Suture-removal area 85 is defined on an outer circumference by interiorwall 35 which extends from a bottom surface of cover 10. Also extendingfrom the bottom surface of cover 10 is a plurality of suture retainingarea protrusions 40. When cover 10 is placed against base 5, sutureretaining area protrusions 40 engage holes 65 formed in base 5.

As discussed with reference to FIGS. 1A and 1B, a suture retaining area30 is defined on an outer boundary by outside wall 15, and an innerboundary by interior wall 35. At the end portion of the suture package,suture retaining area 30 is divided into two or more separate retainingareas by suture retaining area protrusions 40.

Referring now to FIGS. 2A and 2B, there is shown a top view and a sidecross-sectional view, respectively, of an embodiment of a suture package100 in accordance with an embodiment of the present disclosure. Thepackage has a base 105 and a cover 110. An outside wall 115 rises frombase 105 and extends like an oval around a circumference of base 105.Outside wall 115 has an upper rim 120 and a lower rim 125. Lower rim 125is connected to the base 105. Outside wall 115 is designed having apredetermined height such that upper rim 120 engages cover 110,preferably at the circumference thereof. Thus, when base 105 and cover110 are moved adjacent each other, the outer circumference of cover 110is joined with the upper rim 120 of outside wall 115 to form an outerwall of the closed suture package 100.

A suture retaining area 130 is defined on an outer boundary by outsidewall 115, and on an inner boundary by an inner or interior wall 135. Inaccordance with an embodiment of the present disclosure, interior wall135 preferably extends downward from cover 110. Unlike outside wall 115,interior wall 135 is not a continuous loop. Instead, interior wall 135has a first end and a second end which will be described in furtherdetail below. Adjacent to the first end of interior wall 135, an openingis defined which allows a first end of a suture 145 to enter into thesuture retaining area 130. Interior wall 135 is also configured tofollow the shape of the suture retaining area 130. Thus, at the point ofthe opening formed by interior wall 135, the end of the interior wall135 is offset from any other portion of wall 135. This offset isnecessary to maintain the shape of the suture retaining area 130 and toprovide an opening for the suture 145 to access the suture retainingarea 130.

Extending downward from cover 110 is structure which partitions thesuture package into one or more suture retaining areas. Morespecifically, a plurality of sets of four suture retaining areaprotrusions 140 defines a corresponding number of suture retainingareas. The sets of suture retaining area protrusions 140 are displacedradially from a center of the cover 105. It is also contemplated thatthe sets of suture retaining area protrusions may be configured as moreor less than four retaining area protrusions such that more or lesssuture retaining areas are defined. Additionally, it is contemplatedthat the suture retaining area protrusions may be configured as one ormore continuous walls which define one or more suture retaining areas.

Suture retaining area protrusions 140 are elongated finger membershaving a height which is substantially equivalent to the height ofoutside wall 115. Suture retaining area protrusions 140 are connected ona first end to the bottom surface of cover 110. A second end of sutureretaining area protrusion 140 has a post 160 extending therefrom. Posts160 are dimensioned to fit within holes 165 which are formed in base105. Holes 165 may also be dimples or recesses. Posts 160 may also beheat staked or otherwise welded to base 105 to secure the cover 110 tothe base 105. As cover 110 and base 105 are joined together, posts 160extending from suture retaining area protrusions 140 engage holes 165which are defined by base 105. This arrangement provides structuralsupport to the suture package. The ends of the protrusions 140 may,alternatively, be deformed in the manner of rivets after the cover 110has been fitted onto the base 105 with the wall 115. Other and/oradditional types of connection between the wall 115 and the cover 110are possible. Thus, e.g., the use of catches, which project at theperiphery of the cover 110 and engage with suitable counterparts at thewall 115, is conceivable.

Also, as a result of the fit between the suture retaining areaprotrusions 140 and the holes 165 in base 105, the possibility of asurgical suture sticking in the region wherein the suture retaining areaprotrusions 140 meet base 105, as the suture is being removed from thepackaging, is reliably avoided.

More specifically, since, in the preferred embodiment, the suture isremoved through the cover, there will be a tendency for the suture tomove in the direction of the cover 110, which is away from any gap whichmay form at the junction of the suture retaining area protrusions 140and base 105. Thus, this configuration will further an objective of thisembodiment, that is, to increase the reliability of the removability ofthe suture. Although the alternative embodiments described hereininclude various structural differences, a common feature of each of theembodiments is that the structure which forms the suture retaining areasextends from a bottom surface of the cover.

The suture retaining area protrusions 140 define the suture retainingareas 130 on the bottom of cover 110. The embodiment illustrated inFIGS. 2A and 2B includes a plurality of sets of four suture retainingarea protrusions 140 extending radially outward between interior wall135 and outside wall 115. Thus, a suture retaining area 130 defines andprovides for four revolutions of suture 145.

A first end 150 of the suture retaining area 130 opens into asuture-removal area 185 which in the embodiments illustrated in FIGS. 2Aand 2B is arranged in the zone surrounded by the suture retaining area130. The second end 155 of the suture retaining area 130 is closed, seeFIG. 2A. The suture retaining area 130 is closed to the bottom by base105.

Prior to being placed within a suture package, the suture is typicallyattached to a needle to provide a needle-suture-combination. That is, aneedle 170 is fitted onto an end of the suture 145. A needle parkassembly 175 is provided within the central section of thesuture-removal area 185 on an outer surface of cover 110 or an innersurface of base 105. Cover 110 includes an opening which permits freeaccess to the suture-removal area 185. Surgical personnel can gainaccess to the needle and suture through the opening in cover 110 andremove the suture by disengaging needle 170 from needle park 175 andthen pulling the suture 145 from suture retaining area 130. It is to benoted that the needle 170 is positioned within the inner space definedby the suture 145. This configuration further assists in the removal ofthe suture from the package.

FIGS. 3A and 3B illustrate a top view and a side cross-sectional view,respectively, of an embodiment of a suture package 200 in accordancewith another embodiment of the present disclosure. The package has abase 205 and a cover 210. An outside wall 215 rises from base 205 andextends like an oval around a circumference of base 205. Outside wall215 has an upper rim 220 and a lower rim 225. Lower rim 225 is connectedto the base 205. Outside wall 215 is designed having a predeterminedheight such that upper rim 220 engages cover 210, preferably at thecircumference thereof. Thus, when base 205 and cover 210 are movedadjacent each other, the outer circumference of cover 210 is joined withthe upper rim 220 of outside wall 215 to form an outer wall of theclosed suture package 200.

An oval suture retaining area 230 is defined on an outer boundary byoutside wall 215, and on an inner boundary by an interior wall 235. Inaccordance with an embodiment of the present disclosure, interior wall235 preferably extends downward from cover 210. Unlike outside wall 215,interior wall 235 is not a continuous loop. Instead, interior wall 235has a first end 250 and a second end 255. Adjacent to the first end 250,an opening is defined which allows a first end of a suture 245 to enterinto the oval suture retaining area 230. Additionally, a gap ismaintained between the first and second ends 250, 255 to provide accessof a needle 270 to a region in the center of the suture winding.

Interior wall 235 includes a plurality of posts 260 spaced apart andextending therefrom. The height of interior wall 235 is substantiallyequivalent to the height of outside wall 215. Posts 260 are dimensionedto fit within holes 265 which are formed in base 205. Holes 265 may alsobe dimples or recesses. Therefore, as cover 210 and base 205 are joinedtogether, posts 260 extending from interior wall engage holes 265 whichare defined by base 205. This arrangement provides structural support tothe suture package. The posts 260 may, alternatively, be deformed in themanner of rivets after the cover 210 has been fitted onto the base 205with the wall 215. Other and/or additional types of connection betweenthe wall 215 and the cover 210 are possible. Thus, e.g., the use ofcatches, which project at the periphery of the cover 210 and engage withsuitable counterparts at the wall 215, is conceivable.

Prior to being placed within a suture package, needle 270 is fitted ontoan end of the suture 245. A needle park assembly 275 is provided withinthe central section of the suture-removal area 285 on the exteriorsurface of cover 210 or an inner surface of base 205. Cover 210 includesan opening which permits free access to the suture-removal area 285.Surgical personnel can gain access to the needle and suture through theopening in cover 210 and remove the suture by disengaging needle 270from needle park 275 and then pulling the suture 245 from sutureretaining area 230.

Referring now to FIGS. 4A and 4B, there is shown a top view and a sidecross-sectional view, respectively, of an embodiment of a suture package300 having an external needle park in accordance with an embodiment ofthe present disclosure. The suture package 300 is similar to the suturepackage described above with reference to FIGS. 2A and 2B with anexception being the location of the needle park. That is, instead ofpositioning the needle park assembly on the upper surface of base 305,within the central region defined by the suture winding retaining areas330, the needle 370 and needle park assembly 375 are positioned on theupper surface of cover 310. This configuration makes the suture-needlecombination more accessible to the surgical personnel. The surgicalpersonnel would simply disengage the needle 370 from the needle parkassembly 375 and apply a pulling force to pull the suture, which isattached to the needle.

A suture retaining area 330 is defined on an outer boundary by outsidewall 315, and on an inner boundary by an interior wall 335, as describedabove with reference to FIGS. 2A and 2B. Interior wall 335 extendsdownward from cover 310. Also extending downward from cover 310 is aplurality of sets of four suture retaining area protrusions 340 todefine a corresponding number of suture retaining areas.

Referring now to FIGS. 5A and 5B, there is shown a top view and a sidecross-sectional view, respectively, of an embodiment of a suture package400 in accordance with an embodiment of the present disclosure. Thesuture package 400 is similar to the suture package described above withreference to FIGS. 2A and 2B with an exception being the absence ofinner wall 135. That is, instead of having a contiguous inner walldefining the inner boundary of the suture retaining area 430, the innerboundary of suture retaining area 430 is defined by the plurality ofsuture retaining area protrusions 440. Suture 445 is wound within thesuture retaining area 430 defined by suture retaining area protrusions440. The needle 470 and needle park assembly 475 are positioned on theupper surface of base 405 within the central region defined by thesuture retaining areas 430.

Referring now to FIGS. 6A and 6B, there is shown a top view and a sidecross-sectional view, respectively, of an embodiment of a suture package500 in accordance with an embodiment of the present disclosure. Thesuture package 500 is similar to the suture package described above withreference to FIGS. 3A and 3B with an exception being the absence ofinner wall 235. That is, instead of having a contiguous inner walldefining the inner boundary of the suture retaining area 530, the innerboundary of suture retaining area 530 is defined by a plurality ofsuture retaining area protrusions 540. Suture 545 is wound within thesuture retaining area 530 defined by suture retaining area protrusions540. The needle 570 and needle park assembly 575 are positioned on theupper surface of base 505 within the central region defined by thesuture winding retaining areas 530.

Referring now to FIGS. 7A and 7B, there is shown a top view and a sidecross-sectional view, respectively, of an embodiment of a suture package600 in accordance with an embodiment of the present disclosure. Thesuture package 600 is similar to the suture package described above withreference to FIGS. 4A and 4B with an exception being the absence ofinner wall 335. That is, instead of having a contiguous inner walldefining the inner boundary of the suture retaining area 630, the innerboundary of suture retaining area 630 is defined by the plurality ofsuture retaining area protrusions 640. Suture 645 is wound within thesuture retaining area 630 defined by suture retaining area protrusions640. The needle 670 and needle park assembly 675 are positioned on theupper surface of cover 610 within the central region defined by thesuture retaining areas 630.

The packages described herein may be manufactured from conventionalmoldable materials. It is especially preferred to use polyolefinmaterials such as polyethylene and polypropylene, other thermoplasticmaterials, and polyester materials such as nylon, and equivalentsthereof. Preferably, the presently described packages are injectionmolded, however, the packages may be formed by other conventionalprocesses and equivalents thereof including thermo-forming. If desired,the packages may be manufactured as individual assemblies or componentswhich are then assembled.

FIGS. 8 and 9 are perspective views of suture packages in accordancewith embodiments of the present disclosure. The suture packages 800 and900, illustrated in FIGS. 8 and 9, respectively, are similar to eachother and to the suture package described above with reference to FIG.1C, with certain differences. The most significant difference is theaddition of partitions 815 in the embodiment illustrated in FIG. 8.Partitions 815 connect each row of suture retaining area protrusions840. Thus, instead of having individual suture retaining areaprotrusions 940, partitions 815 connect the suture retaining areaprotrusions 840 in a manner which defines a contiguous wall to furtherdefine suture retaining areas 830. Sutures 825 and 925 having needles870 and 970 attached thereto are illustrated wound within sutureretaining areas 830 and 930. The partitions 815 enhance the connectionbetween the cover and base to prevent suture binding. Additionally,benefits associated with the injection molding process are realized withthe embodiment having partitions.

Referring now to FIG. 10, prior to being placed within a suture package,the suture is typically attached to a needle to provide a needle-suturecombination. That is, a needle 970 is fitted onto an end of the suture945. A needle park assembly 975 is provided within the central sectionof the suture-removal area 985 on a surface of cover 910. Needle parkassembly 975 includes a pair of fins 955 and a post 965. Post 965 has acircular cross-section and fins 955 are flexible. Thus, in combination,the characteristics of fins 955 and post 965 provide a three-pointcontact with a needle 970 and allow needle park assembly 975 toaccommodate needles having different curvatures.

It is contemplated that cover 910 defines an opening 990 to provideunrestricted access for surgical personnel to the needle 970. Morespecifically, opening 990 provides surgical personnel with the abilityto insert a needle holder past the surface of the cover. Surgicalpersonnel can gain access to the needle and suture through the opening970 in cover 910 by disengaging needle 970 from needle park 975 and thenpulling the suture 945 from suture retaining area.

Referring now to FIG. 11, it is further contemplated that the assembledsuture packaging 1000 is packed in a foil wrapper (not shown) as isknown to one having ordinary skill in the art. Additionally, in apreferred embodiment, an information label 1015 is attached to an uppersurface of the cover 1010. The information label 1015 includes indicia1025 which, at least in part, provides information regarding thecontents of the suture package. It is preferred that the informationlabel 1015 is attached to the cover 1010 via an adhesive around at leasta portion of a perimeter of the label. When applying the adhesive, careshould be exercised to keep the adhesive from coming into contact withthe needle and/or suture. Information label 1015 is preferably formed ofpaper. A paper label is particularly useful as a moisture sink whenbio-absorbable sutures are used. Information label 1015 illustrated inFIG. 11 does not completely cover the entire surface area of cover 1010.Thus, the surgical personnel will have ready access to needle 1070 aswell as the ability to quickly remove information label 1015.

In contrast to the information label illustrated in FIG. 11, theinformation label 1015 illustrated in FIG. 12 covers the entire surfacearea of cover 1010. The paper information label 1015 includes aplurality of perforations 1035 to define a tear line in a predeterminedlocation. The predetermined location corresponds to a location above andsubstantially perpendicular to the needle 1070 (shown in phantom) whichis parked on the upper surface of the cover 1010. The perforations 1035guide the tear when the surgical personnel open the package and preventthe needle from tipping.

Referring now to FIGS. 13-17, alternative suture package embodiments aredisclosed which are configured to maintain the position of a suturewhile preventing the suture from being caught about the outer peripheryof the package as the suture package base and cover are joined.Referring initially to FIGS. 13-16, the suture package has a base 1105and a cover 1110. A wall 1115 rises from the oval-shaped circumferenceof base 1105. When base 1105 and cover 1110 are assembled to form acomplete suture package, the outer circumference of cover 1110 meets theupper rim of wall 1115. Wall 1115 includes a plurality of protrusions1123 extending inwardly toward a center portion of the suture package.The protrusions 1123 maintain the position of the suture at apredetermined distance toward the center of the suture package toprevent the suture from getting caught in the juncture of wall 1115 andcover 1110 during assembly of the package. Detents 1127 on wall 1115snap into corresponding openings 1125 on the cover 1110 when the baseand cover are assembled. Posts 1140 extend from the inner surface ofcover 1110 through openings 1180 in base 1105 when the package isassembled. Cover 1110 and base 1105 are permanently joined by heatstaking posts 1140.

At each end of the suture package, the suture is retained in an area1130 defined by wall 1115 and posts 1140. Arcuate wall 1145 and wall1146 joining posts 1140 are not intended to contact the suture, butrather improve the structural integrity of the package. Along each sideof the package, there is a portion 1150 where the suture is notrestrained by any structure on either cover 1110 or base 1105 frommovement toward the central portion of the package. Opening 1153 incover 1110 allows removal of the suture from the package.

Cover 1110 includes needle parks 1175 on the outer surface thereof. Aneedle of a suture-needle combination is positioned in needle park 1175which includes three cantilevered members (1155 and 1165) that provide athree-point contact with the needle. See FIGS. 14 and 15. A needle ispositioned with two of the cantilevered members (labeled 1155 in FIG.14) on one side of the needle and a single cantilevered member 1165 onthe other side of the needle. The single cantilevered member 1165 is notcollinear with either of the two cantilevered members 1155.

Referring again to FIG. 15, a depressed area 1170 is provided on theouter surface of cover 1110 to accommodate needles positioned in needleparks 1175. When positioned in the needle park, at least a portion ofthe needle is located over opening 1154 so that the needle can begrasped with a needle holder. A paper label (not shown) applied to thepackage covers at least a portion of depressed area 1170. In addition toproviding information about the product contained in the package, thepaper label protects the outer package from piercing by the point of theneedle(s). Posts 1185 on the outer surface of cover 1110 pass throughthe label and are heat staked to secure the paper label to the cover.

Referring now to FIGS. 16 and 17, another embodiment of a suture packagecover is disclosed, and is identified as reference numeral 1210. At eachend of the suture package cover 1210, a suture is retained in an area1230 which is defined by wall 1115 extending from base 1105 and posts1240. Arcuate wall 1245 and wall 1246 joining posts 1240 are notintended to contact the suture, but rather improve the structuralintegrity of the package. Along each side of the package, there is aportion 1250 where the suture is not restrained by any structure oneither cover 1210 or base 1105 from movement toward the central portionof the package. Opening 1253 in cover 1110 allows removal of the suturefrom the package. The opening 1253 in cover 1210 is configured havingdifferent dimensions than opening 1153 in cover 1110. The purpose of thevarious opening configurations is to accommodate various needle sizesand quantities.

Cover 1210 includes needle parks 1275 on the outer surface thereof. Aneedle of a suture-needle combination is positioned in needle park 1275which includes three cantilevered members that provide a three-pointcontact with the needle. A needle is positioned with two of thecantilevered members (labeled 1255 in FIG. 16) on one side of the needleand a single cantilevered member 1265 on the other side of the needle.The single cantilevered member 1265 is not collinear with either of thetwo cantilevered members 1255.

A depressed area 1270 is provided on the outer surface of cover 1210 toaccommodate needles positioned in needle parks 1275. When positioned inthe needle park, at least a portion of the needle is located overopening 1254 so that the needle can be grasped with a needle holder. Apaper label (illustrated in FIGS. 11 and 12) applied to the packagecovers at least a portion of depressed area 1270. In addition toproviding information about the product contained in the package, thepaper label protects the outer package from piercing by the point of theneedle(s). Posts 1285 on the outer surface of cover 1210 pass throughthe label and are heat staked to secure the paper label to the cover.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, although the aboveembodiments are described with reference to a surgical suture package,it is contemplated that the disclosure is not limited to such anapplication and may be applied to various medical instruments.Additionally, although the illustrative embodiments described hereindisclose a single needle-suture combination within the package, it iscontemplated that multiple sutures may be housed within a single suturepackage. As yet another example, rather than mounting the needle park toa surface of the cover, the needle park can be located on a surface ofthe base. As yet another example, rather than removing the suture-needlecombination through an opening in the cover, it is contemplated that thesuture-needle combination can be removed through an opening formed inthe base. Therefore, the above description should not be construed aslimiting, but merely as exemplifications of preferred embodiments. Thoseskilled in the art will envision other modifications within the scopeand spirit of the claims.

What is claimed is:
 1. A package for at least one surgical suture, thepackage comprising: a base; a cover configured to be placed adjacent tothe base to form the package for the at least one surgical suture,wherein the cover defines an opening therein to provide access to aneedle and suture contained within the package; an outer wall extendingfrom an outer circumference of the base, the outer wall having apredetermined height such that the outer wall meets the cover when thecover is placed adjacent to the base, wherein the outer wall defines anouter periphery of a suture retainer area; a needle park located on anupper surface of the cover for maintaining a needle connected to an endof the surgical suture in a fixed position; a platform extending from abottom surface of the cover, the platform having a peripheral wall forat least partially defining an inner periphery of the suture retainerarea; a plurality of posts extending from first and second arcuate endportions of a lower surface of the cover to define an inner periphery ofarcuate end portions of the suture retainer area, wherein at least twoof the plurality of posts are joined by webbing, and further wherein theposts are dimensioned and configured to engage holes formed in the baseto secure the cover to the base; and a plurality of posts extending froman upper surface of the cover configured for heat staking a label to thecover.
 2. The package for surgical suture material of claim of claim 1further including an information label heat staked to the cover.
 3. Thepackage for surgical suture material of claim 1, further including aplurality of discrete protrusions formed on the outer wall and beingconfigured and dimensioned to maintain the surgical suture material apredetermined distance from the outer wall such that the surgical suturematerial is removed from a juncture formed by the outer wall and thecover upon assembly of the package.
 4. The package for surgical suturematerial as recited in claim 3, wherein the protrusions extend inwardlytoward the center portion of the package.
 5. The package for surgicalsuture material as recited in claim 1, wherein surgical suture materialis wound within the suture retaining area.
 6. The package for surgicalsuture material as recited in claim 5, wherein a needle is attached toan end of the suture material and is positioned within a central regionof the base, as defined by the suture retaining area, such that theneedle engages the needle park to maintain the needle in a fixedposition.
 7. The package for surgical suture material as recited inclaim 5, wherein the suture retaining area is further defined by a wallextending from a lower surface of the cover.
 8. The package for surgicalsuture material as recited in claim 1, wherein the cover has acircumference dimension which is substantially equal to a circumferencedimension of the base.
 9. The package for surgical suture material asrecited in claim 1, wherein the needle park comprises three cantileveredmembers that provide a three-point contact with the needle.
 10. Thepackage for surgical suture material as recited in claim 9, wherein theneedle park is flexible to accommodate needles having differentcurvatures.